Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia

This study has been terminated.
(This study has been terminated early as the esreboxetine development program is being discontinued. There are no safety or efficacy concerns.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00754221
First received: September 16, 2008
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

This is a study to investigate the long-term safety and effectiveness [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.


Condition Intervention Phase
Fibromyalgia
Drug: [S,S]-Reboxetine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Long-term, Open-label Extension Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Vital Signs [ Time Frame: 66 weeks ] [ Designated as safety issue: Yes ]
  • 12-Lead ECG [ Time Frame: 66 weeks ] [ Designated as safety issue: Yes ]
  • Hematology & Biochemistry Laboratory Parameters [ Time Frame: 66 weeks ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 66 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Short-Form 36 Health Survey [ Time Frame: 66 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: 66 weeks ] [ Designated as safety issue: No ]
  • Pain Visual Analogue Scale [ Time Frame: 66 weeks ] [ Designated as safety issue: No ]
  • Multidimensional Assessment of Fatigue [ Time Frame: 66 weeks ] [ Designated as safety issue: No ]
  • Fibromyalgia Impact Questionaire [ Time Frame: 66 weeks ] [ Designated as safety issue: No ]

Enrollment: 390
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: [S,S]-Reboxetine
Once a day, oral treatment, of 4, 6, 8 or 10 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of any race, at least 18 years of age
  • Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
  • Completed preceding double-blind randomized, controlled trial

Exclusion Criteria:

  • Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
  • Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
  • A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
  • History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754221

  Show 111 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00754221     History of Changes
Other Study ID Numbers: A6061053
Study First Received: September 16, 2008
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 3, safety study, [S,S]-Reboxetine, Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014